What are the responsibilities and job description for the Regulatory Affairs Manager position at Route 92 Medical Inc?
About Route 92 Medical
Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention. At the core is a reconsidered procedural approach, cutting-edge engineering, and innovative product design. Our portfolio targets the most significant challenges in neurointerventional care to deliver meaningful solutions. The company was founded by physicians developing thoughtful product solutions in collaboration with the world’s leading clinicians, who focus on improving procedural and patient outcomes.
https://www.route92medical.com/
Chart a new course
Route 92 Medical is looking for dynamic, innovative people who are inspired by our mission to improve outcomes for patients undergoing neurovascular intervention.
We welcome team members who approach their work with courage, flexibility, persistence, and a willingness to assist others. Teamwork matters here. We are committed to collaboration and finding innovative solutions that advance neurovascular intervention, establishing Route 92 Medical as one of the premier companies in the field.
PURPOSE OF JOB:
This Regulatory Affairs Manager will work hybrid at either of our main locations - San Mateo, CA or West Jordan, UT as needed. This position will support Route 92 Medical's efforts to sustain a best practice Quality System by ensuring compliance to regulatory requirements (13485:2016, MDSAP, EU MDR 2017/745) as well as ensuring products meet all applicable internal and external requirements and specifications.
RESPONSIBILITIES:
- Owns products/regions; manages day‑to‑day regulatory activities and small team.
- Translates regulatory strategy into project plans for assigned products and markets.
- Leads preparation and review of submissions and responses to authorities.
- Monitors changes for assigned markets and updates procedures and documentation.
- Ensures regulatory processes are followed; leads regulatory CAPAs and supports audits.
- Represents RA in project teams; provides guidance to R&D, Quality, and Marketing.
- Manages individual contributors; handles workload, coaching, and performance reviews.
- Manages project‑level budgets (consultants, fees, testing) within assigned scope.
- Interfaces with notified bodies, health authorities, and distributors on specific submissions and issues.
- Recommends and implements decisions within established strategy and policies.
- Other regulatory tasks as requested by management.
SKILLS FOR SUCCESS:
- Adaptable to fast-paced environment
- Attention to detail and focus on identification of potential issues and continuous improvement
- Experience with eQMS or RAMs system (e.g.Grand Avenue, DOT Compliance)
REQUIRED EDUCATION:
- Bachelors of Science Degree required
REQUIRED EXPERIENCE:
- Minimum of 8 years work experience in Regulatory Affairs specifically with Medical Device
- At least 2 years in a Management or Leadership role with indirect or direct reports
BENEFITS & PERKS
- Comprehensive healthcare benefits are effective day one! R92M offers generous benefit options, including but not limited to; Medical, Dental, Vision, Life Insurance, FSA, HSA, Short- & Long-Term Disability, Critical Illness Insurance, and Accident Insurance
- Competitive base pay plus corporate bonus program and equity
- Paid vacation and 16 paid holidays, including a company-wide week off in July
- 12 weeks paid parental leave (eligible after 90 days of employment)
- Monthly cell phone stipend
The actual base pay is dependent upon many factors, such as: work experience, market data, skills, geographic location, and business need. The base pay range is subject to change and may be modified in the future. This role may also be eligibility for equity.